Acetaminophen Before Vaccines for Infants Study (AVIS)

A Randomized Placebo-controlled Trial of Acetaminophen for Prevention of Post-vaccination Fever in Infants

The purpose of this study is to see whether giving acetaminophen (the medicine in Tylenol) for routine infant vaccinations is helpful in preventing fever or other symptoms.

Study Overview

• Status: Completed
• Conditions: Fever
• Intervention / Treatment: Drug: Acetaminophen; Other: placebo

Detailed Description

Post-vaccination fever occurs in up to 40% of infants receiving routinely recommended childhood vaccinations. Although serious events are rare, post-vaccination fever causes discomfort for the child, can lead to medical utilization, can rarely result in febrile seizure, and can cause a working parent to miss time from their job to care for a febrile infant who cannot attend day care. The benefits of acetaminophen prophylaxis for infants receiving current vaccinations, in terms of reduction of discomfort for the child, improvement of quality-of-life indicators for the parent, or reduction of medical utilization, have not been measured. This randomized, blinded, placebo-controlled trial will assess the efficacy of prophylaxis with acetaminophen in prevention of fever following routine childhood immunizations.

• Study Type: Interventional
• Enrollment (Actual): 374
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98101
      • Group Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 9 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Child is a current Group Health enrollee.
2. Child will be seen at a Group Health clinic for a Well Child visit that is expected to include 2 or more vaccines after 6 wks and before 10 months of age.

Exclusion Criteria:

1. If child was born at less than 36 weeks of gestation, the child is not eligible until 4 months of age or older.
2. If the child's birth weight was less than 5.5 pounds (2500 grams), the child is not eligible until 4 months of age or older.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Acetaminophen; Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.	Drug: Acetaminophen; Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
Placebo Comparator: Placebo; Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.	Other: placebo; Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fever >=38C Within 32 Hours of Vaccination.	Fever, defined as rectal temperature >=38C within 32 hours of vaccination.	Fever within 32 hours following vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fever >=39C Within 32 Hours of Vaccination.	Fever, defined as rectal temperature >=39C within 32 hours of vaccination.	Fever within 32 hours following vaccination
Study Assignment Unblinded	The need for unblinding at any time during the study	At any time during participation in the study
Medical Utilization	Telephone calls to the consulting nurse or the child's physician that were made due to concerns regarding an acute illness, fever, or possible vaccine reaction and outpatient, urgent care, and emergency room visits that were for evaluation of an acute illness, fever, or a possible vaccine reaction, within 32 hours of vaccination.	Within 32 hours of vaccination.
Infant Fussiness	Parents were asked to record level of fussiness (compared with the child's usual) within 32 hours of vaccination, using the categories much less than usual, less than usual, about usual, more than usual, and much more than usual.	Within 32 hours of vaccination
Parent Time Lost From Sleep	Parents were asked about their sleep on the night following the vaccinations. They were asked to report whether they slept much less than usual, less than usual, about the usual amount, more than usual, or much more than usual on that night.	On the night following vaccinations
Infant Time Lost From Sleep	Parents were asked about their infant's sleep on the night following the vaccinations. They were asked to report whether their infant slept much less than usual, less than usual, about the usual amount, more than usual, or much more than usual on that night.	On the night following vaccinations
Parent Time Lost From Work	Parents were asked to report whether they were scheduled to work on the day of the vaccination visit (but following that visit) or the next day and, if so, whether they had to miss work to care for their infant because of fever, fussiness, or possible vaccine reaction on those days.	Through the day after vaccination

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Lisa A Jackson, MD, MPH, Kaiser Permanente

Publications and helpful links

General Publications

• Jackson LA, Peterson D, Dunn J, Hambidge SJ, Dunstan M, Starkovich P, Yu O, Benoit J, Dominguez-Islas CP, Carste B, Benson P, Nelson JC. A randomized placebo-controlled trial of acetaminophen for prevention of post-vaccination fever in infants. PLoS One. 2011;6(6):e20102. doi: 10.1371/journal.pone.0020102. Epub 2011 Jun 17.

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: May 11, 2006
• First Submitted That Met QC Criteria: May 11, 2006
• First Posted (Estimate): May 15, 2006

Study Record Updates

• Last Update Posted (Actual): October 13, 2017
• Last Update Submitted That Met QC Criteria: October 11, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Vaccination; Acetaminophen; Immunization
• Additional Relevant MeSH Terms: Body Temperature Changes; Fever; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: CDC Protocol #4665